Executive Director, Quality CDMO Management

Role: Executive Director, Quality CDMO Management, overseeing quality operations across Celldex's global external manufacturing network. Responsibilities include developing strategies for quality oversight of commercial CDMOs in the U.S. and Europe, managing vendor relationships, facilitating cross-functional collaboration, and ensuring compliance with GxP regulations. The role involves leading quality events, providing performance metrics, and building a team of quality leaders, with on-site oversight as needed. Requirements: BS in a scientific discipline; extensive experience managing CDMO/CMO quality functions, particularly in biologics manufacturing; strong knowledge of FDA, EMA, ICH, and GMP/GxP standards; proven track record in supplier quality, audits, and regulatory inspections. Preferred qualifications include an advanced degree and leadership in quality systems, deviations, CAPA, and change control. High-Value: biologics manufacturing, GxP compliance, global regulatory standards, cross-functional vendor management, and quality leadership at senior level. WorkSetup: on-site presence required; location not specified.